Functional connectivity–guided transcranial magnetic stimulation for alcohol use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants will undergo fMRI to identify each person's peak brain response to alcohol cues and then receive either active, personalized TMS delivered to that target or a sham procedure. The trial compares one session of fMRI-guided TMS against sham stimulation and monitors changes in brain cue-reactivity and drinking outcomes over follow-up. Eligible participants are adults with DSM-5 moderate-to-severe AUD who can attend in-person visits. The approach aims to use individualized neuroimaging targets to improve the precision and effectiveness of noninvasive neuromodulation for relapse prevention.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Between age 25 and 75.
* Current DSM-5 diagnosis of moderate to severe AUD (≥4 diagnostic symptoms).
* Able to attend scheduled clinic visits
* Able to read, understand and voluntarily sign Informed Consent prior to participating in any study-specific procedures or assessments.
* If on a medication regimen, that regimen will be stable for the duration of the study;
* Fluency in English.

Exclusion Criteria:

* Transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI) contraindications: such as a cardiac pacemaker, cochlear implant, or an implanted device (deep brain stimulation, metal in the head, metal in the body, claustrophobia, pregnant or breastfeeding or other ferromagnetic device/objected in the head and body within 30 cm of the treatment coil.
* General medical condition, disease or neurological disorder that interferes with the assessments or participation.
* Unable to safely withdraw, at least two weeks prior to treatment, from medications that increase seizure risk.
* Current substance abuse (except caffeine or nicotine) as determined by positive toxicology screen.
* Have a mass lesion, cerebral infarct, or other active CNS disease, including an alcohol-related seizure or a seizure disorder. • A recent suicide attempt (defined as within the last 30 days) or presence of current suicidal plan or intent. Patients at risk for suicide will be required to establish a written safety plan involving their primary therapist before entering the study.
* Severe impediment to vision, hearing and/or hand movement, likely to interfere with the ability to follow study protocols. • Greater than mild traumatic brain injury (defined as greater than 10 minutes loss of consciousness).
* Taking benzodiazepine or neuroleptic medications, or any medication known to alter seizure threshold
* unstable chronic illness.
* Current or lifetime history of bipolar disorder or psychosis.
* Participation in another concurrent intervention based clinical trial.

Where it's running

• VA Palo Alto Health Care System
  Palo Alto, California, United States Recruiting

Study contacts

• Principal investigator: Daniel McCalley, PhD — Palo Alto VA Health Care System
• Study coordinator: Daniel McCalley
• Email: mccalled@stanford.edu
• Phone: 650-493-5000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.